US-Nationwide, CRA (Devices)

CRA’s

(Regional with Device experience)

Seeking Regional Monitors for great opportunity with fabulous client!

The Role and your Responsibilities

The Sr. Clinical Research Associate is responsible for establishing, managing and meeting the milestones of a clinical study in compliance with applicable clinical and regulatory standards and in alignment with business needs. This role works independently and under only general direction. Major deliverables are reviewed to ensure clinical and business requirements are met. This position may also serve as a trial manager depending on the complexity of the trial and may provide work direction to other team members supporting the trial. The role ensures that clinical study management including the design, initiation, management, monitoring and closing of the study are appropriately executed for either their assigned sites.

Position Responsibilities

Follow all work/quality procedures to ensure quality system compliance and high quality work.

Drives process to determine study objectives, strategy, scope, and schedule in order to meet business needs

Supports interactions with regulatory agencies including meetings with the Food and Drug Administration (FDA) and FDA panel meetings regarding requirements and results of the study.

Ensures site activities in line with milestones (i.e. startup, recruitment, closeout, etc) and implement contingency plans as needed

Responsible for accurate and timely adverse event reporting during the study.

Will ensure site adherence to FDA, Regulatory, IRB and sponsor requirements.

Work with investigators to quickly and effectively resolve problems.

Evaluates clinical data/information and prepares interim and final reports.

What is Required

BS or BA with a minimum of 4+ years of Monitoring

2+ years of device experience (recently - within the past 3-5 years)

Clinical research includes:

Industry sponsored clinical research, physician sponsored clinical research, and government sponsored clinical research, or any other clinical research that would lead toward regulatory submission, review, and approval for market clearance.

Similar medical/scientific experience (e.g., has written and implemented protocols for experiments or animal research, has a good understanding of the research process) may be acceptable.

Ability to travel 40-75%

What is Offered

DOCS clients include small, mid and large sized Pharmaceutical companies in addition to many leading Biotechnology, Medical Device companies and CROs. As a global partner, DOCS currently offers global resourcing solutions to our clients.

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considered, please do so. Applications for all positions are subject to each employer's specific requirements.